ADVERSE REACTIONS SECTION.

Transient stinging, burning, itching or irritation may occur and normally disappearon discontinuing the medication.

CLINICAL PHARMACOLOGY SECTION.

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

CONTRAINDICATIONS SECTION.

Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

CEM-UreaTM (45% Urea) is keratolytic emollient, which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of CEM-UreaTM (45% Urea) contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, methyl paraben, propylene glycol and purified water.Urea is diamide of carbonic acid with the following chemical structure:.

DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by physician. DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by physician.

HOW SUPPLIED SECTION.

CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20.

INDICATIONS & USAGE SECTION.

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.

NURSING MOTHERS SECTION.

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when CEM-UreaTM (45% Urea) is administered to nursing woman.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 42546-100-20CEM-Urea Pre-Filled Applicator 45% urea In vehicle containing Menthol, Camphor, and Eucalyptus Oil Rx only0.68 FL OZ (20 mL) PruGen, Inc. Pharmaceuticals. image of tube label.

PHARMACOKINETICS SECTION.

The mechanism of action of topically applied Urea is not yet known.

PREGNANCY SECTION.

Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studiesin pregnant women. Because animal reproductive studies are not always predictive of human response, CEM-UreaTM (45% Urea) should be given to pregnant woman only if clearly needed.

STORAGE AND HANDLING SECTION.

Store at controlled room temperature 15-30 (59-86 F).Protect from freezing.

WARNINGS AND PRECAUTIONS SECTION.

For external use only. Avoid contact with eyes, lips or mucous membranes.This medication is to be used as directed by physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.